Drugs
The Alliance for Aging Research says it is encouraged that FDA is continuing to urge industry and other stakeholders to enroll diverse populations in their clinical trials, and especially older adults. Commenting on an agency draft guidance on inclusion of older adults in cancer clinical trials, the alliance says the
Drugs
Taiho Oncology is asking FDA not to permit companies to carve out of the approved Lonsurf (trifluridine and tipiracil) labeling the language that relates to dose reduction in severely renally impaired patients. “The carving out of dose reductions in severely renally impaired patients will result in labeling that will present
Drugs
Some 56 pro-life and other advocacy groups are urging FDA to seize the Web site domains for AidAccess, Rablon, and any other entities illegally prescribing and/or selling mifepristone in the U.S. “We urge FDA to protect women from the distributors of abortion-inducing drugs who place lives
Drugs
FDA has accepted a Lipocine IND to begin a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioidentical testosterone, for treating liver cirrhosis in adult males. The planned study is a prospective, multi-center, randomized, placebo-controlled 52-week trial
Drugs
FDA has approved a Tolmar Pharmaceuticals NDA for Fensolvi (leuprolide acetate) for injectable suspension for treating pediatric patients two years of age and older with central precocious puberty (CPP). The rare disease is defined as the onset of puberty before age eight in girls and before age nine in boys,
Drugs
FDA has accepted for review a KemPharm NDA for its investigational product candidate KP415 (serdexmethylphenidate) for treating attention deficit hyperactivity disorder (ADHD). The company is expecting a user fee review action target of 3/2021. Serdexmethylphenidate is KemPharm’s prodrug of d-methylphenidate (d-MPH) and was designed to address
Drugs
FDA’s moratorium on domestic and foreign inspections during the Covid-19 emergency has been extended indefinitely. In early March, FDA first postponed foreign inspection of regulated products until 5/1. Shortly thereafter, domestic inspections were postponed too. FDA spokesman Jeremy Kahn told FDA Webview 5/4 that the agency
Drugs
Rep. Anna G. Eshoo (D-CA) and Rep. Susan W. Brooks (R-IN) have introduced bipartisan legislation entitled Prescription for American Drug Independence Act. The legislation would require the National Academies of Sciences, Engineering, and Medicine to convene a committee of experts to analyze the U.S.’s dependence on
Drugs
FDA has issued an updated guidance on “Investigational Covid-19 Convalescent Plasma.” The document provides recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from Covid-19. It also provides recommendations to blood establishments on collecting convalescent
Drugs
FDA has granted Gilead Sciences an emergency use authorization for its antiviral drug remdesivir for treating suspected or laboratory-confirmed Covid-19 in adults and children hospitalized with severe disease. “While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital
Drugs
FDA has approved a Janssen Biotech BLA for subcutaneous Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. Approval is based on data from the Phase 3 COLUMBA and Phase 2 PLEIADES studies, which showed that the fixed-dose subcutaneous formulation reduced
Drugs
FDA has accepted for review a Bristol Myers Squibb NDA for CC-486, an investigational oral hypomethylating agent for the maintenance treatment of adult patients with acute myeloid leukemia (AML). The drug is intended for patients who achieved complete remission (CR) or CR with incomplete blood count recovery, following induction
Drugs
A task force from BioPhorum and the Pharmaceutical Process Analytical Round Table tells FDA the pharmaceutical and biopharmaceutical industries are facing challenges and uncertainties with regards to regulatory expectations for the validation, registration, and lifecycle management of multi-variate data analysis (MVDA) models used in process analytical technology and real-
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) describing the policies and procedures for collaborative identification, evaluation, and resolution of a newly identified safety signal (NISS) associated with marketed drugs. The MAPP notes that multiple Center offices have roles in identifying, evaluating, and resolving a NISS, depending on
Drugs
The Utah federal court has issued a temporary restraining order to stop two companies and their owner from selling silver products for the treatment and prevention of Covid-19. A Justice Department statement says the injunction was entered against Gordon Pedersen, Cedar Hills, UT, and his companies My Doctor Suggests
Drugs
The CBER Office of Compliance and Biologics Quality says its review of the Web site maintained by Infuze MD, Milpitas, CA, determined that the firm markets “IV Stem Cell Therapy,” administered intravenously to treat several diseases or conditions. A 4/27 Notice of Violation said CBER also determined that at
Drugs
FDA has approved a new Boxed Warning for labeling for Merck’s Singulair (montelukast) and generics to increase awareness of potential mental health side effects. An agency notice says the Boxed Warning will be added to both the prescribing information and a medication guide. The notice says FDA took the
Drugs
Vascular Solutions has recalled (Class 1) the Langston Dual Lumen Catheter due to the potential for the inner catheter to separate during use. If the separation occurs, it could cause serious health conditions including additional surgical procedures to remove the separated section, damage to the blood vessel or death, a
Drugs
FDA says GSK Consumer is recalling five lots of its Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to the potential for green plastic pieces or shavings from bottle caps to be in the product. A recall notice says there is a potential risk
Drugs
Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) have released a concept paper for their bipartisan “Cures 2.0.” The two say the paper looks at high levels of focus for Cures 2.0, which will look to safely and efficiently modernize the delivery of healthcare in the
Drugs
The Association of American Physicians and Surgeons (AAPS) has written Arizona governor Doug Ducey asking that he rescind a month-old moratorium forbidding prophylactic use of chloroquine (CQ) or hydroxychloroquine (HQ) during the Covid-19 pandemic unless peer-reviewed evidence becomes available. In the 4/27 letter, the association links
Drugs
FDA says QuVa Pharma is recalling all lots of RECK (ropivacaine, epinephrine, clonidine, ketorolac) 50 ml in sodium chloride-60 ml BD syringe that were prepared using sterile ketorolac being recalled by Fresenius Kabi. An FDA recall notice says Fresenius recalled multiple lots of ketorolac 4/20 due to the